MAUDE Adverse Event Report: SAGE PRODUCTS LLC IND CARE KIT W/ CORINZ 50; MANUAL TOOTHBRUSH

Catalog Number 6004

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

Reporter did not provide involved device or photographs of the device, therefore a visual inspection could not be completed.A product history review could not be performed because the lot information of the affected material was not provided.Without lot information or more information as to what was falling apart on the toothbrush, a root cause could not be determined.

Event Description

Report received that toothbrushes were falling apart.The reporter stated that the toothbrush from sage #6004 independent care kit is falling apart and staff are having to open a new kit for a new toothbrush.No samples, lot information, or photographs were provided.Although several attempts were made to obtain additional information, reporter has not responded.

Manufacturer Narrative

On 11/05/2021 new information was received from the reporter stating the bristles easily fall out of the toothbrush.Otherwise, no new additional information was provided.Without the returned product, photographs or lot information, the specific root cause for bristle disengagement could not be determined.

Event Description

Report received that toothbrushes were falling apart.The reporter stated that the toothbrush from sage #6004 independent care kit is falling apart and staff are having to open a new kit for a new toothbrush.No samples, lot information, or photographs were provided.Although several attempts were made to obtain additional information, reporter has not responded.11/05/2021- reporter provided additional information stating the bristles of the toothbrush fall out easily.Reporter did not provide any further information.

Manufacturer Narrative

Udi-di was inadvertently omitted in previous submission.

Event Description

Report received that toothbrushes were falling apart.The reporter stated that the toothbrush from sage #6004 independent care kit is falling apart and staff are having to open a new kit for a new toothbrush.No samples, lot information, or photographs were provided.Although several attempts were made to obtain additional information, reporter has not responded.11/05/2021- reporter provided additional information stating the bristles of the toothbrush fall out easily.Reporter did not provide any further information.

• Brand Name: IND CARE KIT W/ CORINZ 50
• Type of Device: MANUAL TOOTHBRUSH
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• Manufacturer (Section G): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• Manufacturer Contact: susie hinkle ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 12249359
• MDR Text Key: 264509393
• Report Number: 0001419181-2021-00012
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 07/02/2021; 07/02/2021
• Supplement Dates FDA Received: 11/11/2021; 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1